Patent lawyers shouldn’t look to the U.S. Supreme Court for any additional guidance on diagnostic method patents or the contours of the Hatch-Waxman Act’s safe harbor.
That’s because the high court refused to take up petitions from the Cleveland Clinic Foundation or Classen Immunotherapies Inc.
The high court declined to review a decision from the U.S. Court of Appeals for the Federal Circuit invalidating three Cleveland Clinic Foundation patents on methods to test for arterial damage. The tests detect the presence of an enzyme the body releases when there is arterial damage or inflammation.
Inventions that are directed to natural phenomenon aren’t eligible for patent protection unless there is an inventive concept, which the patents didn’t have, the appeals court said.
The Cleveland Clinic case illustrates the difficulties in getting patents on medical diagnostic methods.
The high court’s failure to take up the Cleveland Clinic’s petition for review in the Cleveland Clinic Foundation v. True Health Diagnostics case means an already murky area of patent law will remain murky for now. It also means continued obstacles for biotechnology innovators who could have more difficulty attracting investment because of the uncertainties surrounding getting patents on their inventions.
The high court also refused to take up Classen Immunotherapies Inc.'s invitation to review a case involving whether Perrigo PLC subsidiary Elan Pharmaceuticals Inc.'s provision of information on the safety and efficacy of its muscle relaxant to the FDA infringed a Classen patent.
In that case, the U.S. District Court for the District of Maryland, on remand from the Federal Circuit, ruled Elan's provision of information on the safety and efficacy of Skelaxin to the FDA fell within the safe harbor provision. The information submission related to a revision to Skelaxin's product label and proposed changes to the approval requirements for generic versions of the drug.
The Hatch-Waxman Act's safe harbor is important to companies on both sides of pharmaceutical patent litigation because it can exempt from infringement liability any activity that's “reasonably related to the development and submission of information” to the Food and Drug Administration. The harbor is typically used by generic companies that perform certain activities prior to the market launch of their products.
Read my article here.
Stay on top of new developments in health law and regulation, and learn more, by signing up for a free trial to Bloomberg Law.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)